Siemens Mammomat Inspiration — Class II medical device recall Z-1694-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-07-17, distributed nationwide. Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a
| Recall number | Z-1694-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2013-02-28 |
| Classified | 2013-07-11 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2014-02-21 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Reason classes | device malfunction |
| Serial numbers | 3118, 3243, 3309 |
| Model numbers | 10140000 |
Product
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Reason for recall
Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this iss
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1694-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.